Form Fda 3419 (3/99) - Medical Device Reporting Annual User Facility Report Form
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1
2DEPARTMENT OF HEALTH AND HUMAN SERVICES
OMB: 0910-0059
MEDICAL DEVICE REPORTING
PUBLIC HEALTH SERVICE
Exp. Date: 06/30/2000
FOOD AND DRUG ADMINISTRATION
ANNUAL USER FACILITY REPORT
CDRH Medical Device Reporting
P.O. Box 3002
PART 1 - COVER SHEET
Rockville, MD 20847-3002
If MDR reports were not submitted to either the FDA or a device manufacturer during this reporting period, DO NOT submit an
annual report.
PART 1 INSTRUCTIONS
Complete one copy of the following information as a cover page for the annual report and return to the address
listed above. This report should NOT include reports that are not required but have been submitted voluntarily.
1. REPORT PERIOD
2. USER FACILITY ID (HCFA OR FDA PROVIDED NUMBER)
JAN - DEC
Y Y Y Y
3. USER FACILITY INFORMATION
4. USER FACILITY CONTACT INFORMATION
a. Name
a. Name
b. Street Address
b. Street Address
c. City
d. State
e. ZIP Code
c. City
d. State
e. ZIP Code
f. Country/Postal Code (if not U.S.)
f. Country/Postal Code (if not U.S.)
g. Telephone Number (Include area code and extension)
(
)
5. TOTAL NUMBER OF REPORTS ATTACHED OR SUMMARIZED
-
-
a. Lowest Report Number
(HCFA or FDA Provided No.)
(Year)
(Sequence No.)
-
-
b. Highest Report Number
(HCFA or FDA Provided No.)
(Year)
(Sequence No.)
For each report in the range of report numbers listed above, attach a completed copy of Part 2 of this form, or a photocopy of the completed
MedWatch FDA Form 3500A for the event that was sent to FDA and / or the manufacturer. In addition, attach a sheet listing report numbers in the
above range that are not included in this report and explain why.
7. DATE OF REPORT
6. SIGNATURE OF CONTACT
/
/
M
M
D D
Y Y Y Y
Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 1 hours per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Food and Drug Administration
CDRH Medical Device Reporting
P.O. Box 3002
Rockville, MD 20847-3002
FORM FDA 3419 (3/99)
(Continue on Page 2, if necessary)
Created by Electronic Document Services/USDHHS: (301) 443-2454
PAGE 1
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